Senior Statistical Data Scientist

1 week ago

tiruchirappalli, India beBeeStatistical Full time

Job OverviewAs a Global Lead Statistical Programmer, you will be responsible for leading and managing statistical programming activities in various studies and projects. This role requires a strong understanding of pharmaceutical clinical development, regulatory submissions, and CDISC standards.The ideal candidate will have excellent SAS programming skills, experience working with clinical trial data, and a solid understanding of statistical concepts and techniques.Key Responsibilities:Lead statistical programming activities for therapeutic areas or compounds/indications within multiple studies/projectsDevelop and maintain programming documentations following programming standards and processesOversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standardsContribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standardsParticipate in CRF annotation, review of SAP, TLFs specifications development and TLFs reviewHandle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for regulatory submission to FDA/EMA/PMDA or other agenciesRequirements:Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industryOncology Therapeutic area preferredStrong SAS programming skills in a clinical data environment with excellent analytical skillsGood knowledge of pharmaceutical clinical development and regulatory submissions (NDA, ANDA etc.)Extensive working knowledge of using and implementing CDISC standards

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